Throughout this specification, when discussing the aorta or other blood vessels, the terms distal and distally with respect to a prosthesis are intended to refer to the end of the prosthesis furthest away in the direction of blood flow from the heart. Similarly, the terms proximal and proximally are intended to mean the end of the prosthesis which, when implanted, would be nearest to the heart.
The aorta, as are all arteries, is made up of three layers. The inner layer of the aorta is known as the tunica intima, and comprises mainly endothelial cells. The middle layer of the aorta is called a tunica media, and consists of smooth muscle and elastic tissue. The outer layer of the aorta is referred to as the tunica adventitia, and is composed of connective tissue.
An aortic dissection is a tear or partial tear in the tunica intima, or lining, of the aorta. This tear results in a “flap” at the opening, which may occlude blood flow in the aorta. In an aortic dissection, blood penetrates the intima through the tear, and enters the media. The pressure of the blood rips the layers of the media apart, allowing more blood to enter. This process can propagate a tear along the length of the aorta for some distance, creating a blood filled channel known as a “false lumen”. Over time, such a continuous flow of blood through a false lumen may cause the aorta to rupture, a serious condition often resulting in death.
There are two types of aortic dissections under the Stanford rating system. A dissection of the ascending aorta is classified as a Type A dissection. A dissection of the descending aorta is classified as a Type B dissection. Type A dissections can be treated medically, but usually only briefly. Type A dissections are usually treated with interventional catheterization or open surgical techniques. Type B dissections are most often treated medically with routine monitoring and prescribed medications. Type B dissections may also be treated surgically, but this option carries substantially increased risk of paralysis, and therefore is not commonly preformed.
The deployment of intraluminal prostheses into the lumen of a patient from a remote location by the use of a deployment device or introducer has been disclosed in a number of earlier patens and patent applications. U.S. Pat. No. 4,562,596 entitled “Aortic Graft, Device and Method for Performing an Intraluminal Abdominal Aortic Aneurysm Repair” proposes the retention of a self-expanding graft within a sleeve until it is to be deployed, at which time the sleeve is withdrawn and the graft is allowed to expand. These features and other features disclosed in U.S. Pat. No. 4,562,596 could be used with the present invention and the disclosure of the U.S. Pat. No. 4,562,596 is herein incorporated by reference.
U.S. Pat. No. 4,665,918 entitled “Prosthesis System and Method” proposes a system and method for the deployment of a prosthesis in a blood vessel. The prosthesis is positioned between a delivery catheter and an outer sheath and expands outwardly upon removal of the sheath. These features and other features disclosed in U.S. Pat. No. 4,665,918 could be used with the present invention and the disclosure of the U.S. Pat. No. 4,665,918 is herein incorporated by reference.
U.S. Pat. No. 4,950,227 entitled “Stent Delivery System” proposed the delivery of a stent by mounting the stent to the outside of an inflatable catheter and retaining the ends of an unexpanded stent by fitting a sleeve over either end of the stent. Expansion of the stent is caused by inflation of the catheter between the sleeves so that the ends of the stent are withdrawn from the respective sleeves and the stend released and expanded into position. These features and other features disclosed in U.S. Pat. No. 4,950,227 could be used with the present invention and the disclosure of the U.S. Pat. No. 4,950,227 is herein incorporated by reference.
U.S. Pat. No. 5,387,235 entitled “Endovascular Transluminal Graft Prosthesis for Repair of Aneurysm” discloses apparatus and methods fo retaining grafts onto deployment devices. These features and other features disclosed in U.S. Pat. No. 5,387,235 could be used with the present invention and the disclosure of the U.S. Pat. No. 5,387,235 is herein incorporated by reference.
U.S. Pat. No. 5,720,776 entitled “Barb and Expandable Transluminal Graft Prosthesis for Repair of Aneurysm” disclosed improved barbs with various forms of mechanical attachment to a stent. These features and other features disclosed in U.S. Pat. No. 5,720,776 could be used with the present invention and the disclosure of the U.S. Pat. No. 5,720,776 is herein incorporated by reference.
U.S. Pat. No. 6,206,931 entitled “Graft Prosthesis Materials” discloses graft prosthesis material and a method for implanting, transplanting, replacing and repairing a part of a patient and particularly the manufacture and use of a purified, collagen based matrix structure removed from a submucosa tissue source. These features and other features disclosed in U.S. Pat. No. 6,206,931 could be used with the present invention and the disclosure of the U.S. Pat. No. 6,206,931 is herein incorporated by reference.
PCT Patent Publication Number No. WO99/29262 entitled “Endoluminal Aortic Stents” discloses a fenestrated prosthesis for placement where there are intersecting arteries. This feature and other features disclosed in PCT Patent Publication Number No. WO99/29262 could be used with the present invention and the disclosure of PCT Patent Publication Number No. WO99/29262 is herein incorporated by reference.
PCT Patent Publication Number No. WO03/034948 entitled “Prostheses for Curved Lumens” discloses prostheses with arrangements for bending the prosthesis for placement into curved lumens. This feature and other features disclosed in PCT Patent Publication Number No. WO03/034948 could be used with the present invention and the disclosure of PCT Patent Publication Number No. WO03/034948 is herein incorporated by reference.
United States Patent Application Publication No. 2003/0233140 entitled “Trigger Wire System” discloses release wire systems for the release of stent grafts retained on introducer devices. This feature and other features disclosed in United States Patent Application Publication No. 2003/0233140 could be used with the present invention and the disclosure United States Patent Application Publication No. 2003/0233140 is herein incorporated by reference.
United States Patent Application Publication No. 2004/0098079 entitled “Thoracic Aortic Stent Graft Deployment Device” discloses introducer devices adapted for deployment of stent grafts particularly in the thoracic arch. This feature and other features disclosed in United States Patent Application Publication No. 2004/0098079 could be used with the present invention and the disclosure United States Patent Application Publication No. 2004/0098079 is herein incorporated by reference.
United States Patent Application Publication No. 2004/0054396 entitled “Stent-Graft Fastening” discloses arrangements for fastening stents onto grafts particularly exposed stents. This feature and other features disclosed in United States Patent Application Publication No. 2004/0054396 could be used with the present invention and the disclosure United States Patent Application Publication No. 2004/0054396 is herein incorporated by reference.
PCT Patent Publication Number No. WO03/053287 entitled “Stent Graft with Improved Graft Adhesion” discloses arrangements on stent grafts for enhancing the adhesion of such stent grafts into walls of vessels in which they are deployed. This feature and other features disclosed in PCT Patent Publication Number No. WO03/053287 could be used with the present invention and the disclosure of PCT Patent Publication Number No. WO03/053287 is herein incorporated by reference.
PCT Patent Publication Number No. WO98/53761 entitled “A Prosthesis and a Method and Means of Deploying a Prosthesis”, which is herein incorporated by reference, discloses various embodiments fo an introducer for positioning an expandable endovascular prosthesis in a lumen of a patient that could be used with the present invention.